Phase 2
N=18
Cannabidiol Treatment in Patients With Early Psychosis
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02504151 ↗Enrolled (actual)
18
Serious AEs
11.1%
Results posted
Sep 2022
Primary outcome: Primary: Positive and Negative Syndrome Scale (PANSS) Over Time — 81.3; 84.0; 78.3; 75.3 score on a scale — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cannabidiol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive and Negative Syndrome Scale (PANSS) Over Time |
81.3; 84.0; 78.3; 75.3; 81.4; 73.9 | 0.08 |
| PRIMARY Clinical Global Impression of Severity Scale Over Time |
4.1; 4.2; 4.1; 4.2; 4.4; 4.2 | 0.48 |
| SECONDARY Patient Assessment of Own Functioning Inventory (PAOFI) Over Time |
90.1; 85.1; 85.3; 87.5; 95.3; 74.9 | 0.485 |
| SECONDARY Quality of Life Scale (QLS) Over Time |
70.4; 72.9; 73.4; 74.9; 69.9; 67.1 | 0.994 |
Summary
Cannabidiol (CBD) is a component of herbal cannabis that is present in varying concentrations in cannabis extracts. CBD has been shown to produce central effects including hypnotic, anticonvulsive, anxiolytic and neuroprotective effects.The investigators hypothesize that treatment with CBD will result in: 1) Improvement evidenced by a reduction in scores on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2) Improvement evidenced by a reduction in the Clinical Global Impression of Severity scale (CGI); Secondary Hypothesis: 1) Greater improvement in functioning as measured on the "Patient Assessment of Own Functioning Inventory: (PAOFI) and the Quality of Life Scale (QLS) In this 2 period cross over design, subjects will be randomized in a 1:1 ratio to receive either: Order 1: CBD (Period 1) followed by placebo (Period 2) or Order 2: Placebo (Period 1) followed by CBD (Period 2) under double-blind conditions. The 2 study periods will be separated by a washout of at least 2 weeks. During each period subjects will receive study medications (CBD [total 800mg/day] or placebo) for a period of 4 weeks.
Eligibility Criteria
Inclusion Criteria
- Male or female
- Primary psychotic disorder
- Ages 18-65 (inclusive)
Exclusion Criteria
- Current significant medical condition or other comorbidities
- Current substance depdendence
- Women who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT02504151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.